# Safety and efficacy of a feed additive consisting of l‐lysine sulfate produced using Corynebacterium glutamicum KCCM 80368 for all animal species (CJ Europe GmbH)

## TL;DR

The paper evaluates the safety and effectiveness of l-lysine sulfate produced using a genetically modified bacterium for use in animal feed.

## Contribution

It confirms the safety of the genetically modified strain and its use in feed for all animal species.

## Key findings

- The additive is safe for target species, consumers, and the environment.
- The additive is a safe and effective source of l-lysine for non-ruminant animals.
- It should be protected from ruminal degradation to be effective in ruminants.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐lysine sulfate produced by fermentation using the genetically modified strain of Corynebacterium glutamicum, KCCM 80368, as a nutritional additive in feed for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the additive does not give rise to any safety concern regarding the genetic modification of the strain. DNA from the strain is present in the final product, but its presence does not raise any safety issue since the strain does not harbour any gene of concern. No viable cells of the strain were detected in the final product. The use of l‐lysine sulfate produced using C. glutamicum KCCM 80368 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the species. The use of the additive in animal nutrition is considered safe for the consumers of products from animals receiving the additive, and to the environment. With regard to the safety for the user, the additive is not irritant to the skin, but no conclusions could be reached on the eye irritation potential. The additive should be considered as a skin and respiratory sensitiser. Exposure by inhalation and dermal routes is considered a risk. The additive l‐lysine sulfate produced using C. glutamicum KCCM 80368 is regarded as an effective source of the amino acid l‐lysine for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.